TerminatedNot Applicable

Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)

Stopped: slower than target enrollment.

Hong Kong50 participantsStarted 2020-01-01

Plain-language summary

Pericardial effusion is a common complication in patients with metastatic malignancy. While pericardiocentesis provide effective relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial effusion after pericardiocentesis is common. We hypothesize that percutaneous balloon pericardiotomy in addition to standard pericardiocentesis with prolonged drainage can prevent pericardial effusion recurrence in patients with malignant pericardial effusion.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with confirmed active malignancy AND, * Presence of at least moderate (\>10cm) pericardial effusion on CT or Echocardiography Exclusion Criteria: * Patients unable to give an informed consent, * Previous history of open-heart surgery * Previous history of pericardial window or pericardial instillation of sclerosing therapy. * Scheduled thoracic or cardiac surgery within the next 3 months * Patients with contraindications for endovascular procedure such as disseminated intravascular coagulopathy or significant ongoing bleeding tendency, and systemic septicaemia. * Patient with small or loculated pericardial effusion that is not accessible by subxiphoid approach.

What they're measuring

Pericardial effusion recurrence

Timeframe: 3 months

Procedural related complications

Timeframe: Immediate after intervention

Trial details

NCT IDNCT04472468

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-28

View on ClinicalTrials.gov More Pericardial Effusion Malignant trials